Health Status, Quality of Life and Function in Survivors After Radical Treatment for Prostate Cancer. A Cross-sectional Study Focusing on Older Survivors. Part I and IIA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 657
- 试验地点
- 1
- 主要终点
- Global quality of life
研究概览
简要总结
In this study, addressing prostate cancer survivors, i.e. men who received potentially curative (radical) treatment two to six years ago, we will investigate if older age at time of treatment is a detrimental factor with respect to long-term quality of life (Qol), health, and function. We will also compare QoL, health and function between the prostate cancer survivors and matched population based cohorts, and thereby provide realistic information on the long-term impact of radical prostate cancer treatment
详细描述
Prostate cancer is the most common male cancer in Norway, with almost 5000 new cases yearly. More than12 % of men contract prostate cancer before the age of 75. As 5-year survival is high (>95%), a significant proportion of the older male population are prostate cancer survivors. The quality of life (QoL) and daily function of these older males need elucidation to provide adequate health care services and information to this large patient group.
The present project includes two studies(Study I and IIA). Study I is investigating the QoL, health status, and local adverse treatment effects in all men 2-6 years after radical treatment for prostate cancer. Local adverse treatment effects are defined as problems related to organs and structures adjacent to the prostate gland (e.g. bowel and urinary problems, and sexual dysfunction). Study IIA will focus on older prostate cancer survivors, defined as men who were 70 years or older by the time of treatment. To complete the overall project, we also plan a later study, Study IIB, that will investigate in more detail the physical functioning and performance of the older survivors.
Design Study I: A cross-sectional survey targeting all patients from the catchment area of Innlandet Hospital Trust (SI-HF) who received radical treatment for localized/locally advanced prostate cancer at SI-HF from 2014 to 2018 Study II A: A supplementary cross-sectional survey targeting older participants from Study I who were >70 years at time of treatment Control groups: For comparison with a general population, we will use existing data from male participants in the fourth wave of the Trøndelag Health Study (HUNT4) including the HUNT4 70+ survey. Control groups will be drawn, matched on age and education. HUNT4 and HUNT4 70+ were both performed in 2017-2019, and targeted all inhabitants and inhabitants >70 years respectively in the former Nord-Trøndelag County. Jointly they include broad health assessments using questionnaires, physical examinations, and tests.
Study aims Primary study aims are
- to investigate if older age at the time of radical treatment has a negative impact on self-reported QoL, function and local adverse effects in prostate cancer survivors
- to investigate if health status, health problems, and use of health care services in older prostate cancer survivors differ from a general male population of the same age
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Global quality of life
时间窗: at time of assessment (cross-sectional)
Global quality of life assessed by the EORTC QLQ-C30 questionnaire's global QoL scale ranging from 0 to 100, higher scores indicate better QoL
General health
时间窗: at time of assessment (cross-sectional)
self-reported using items from the Trøndelag Health Survey 4, categorical scale: bad/not so go good/good/very good
次要结局
- EPIC-26 scores(at assessment (cross-sectional))
- physical function(at assessment (cross-sectional))
- Activities of daily living(at assessment (cross-sectional))